BluePoint Laboratories

Farmaceutisch bedrijf4 producten gevolgd

producten gevolgd

122.013

totaal meldingen

recalls geregistreerd

79,9%

ernstig algeheel

Producten

4 van 4 getoond

Product	Goedgekeurd	Meldingen ↓	Top signaal	Recalls
etoposide —	1983	73.031	koortsige neutropenie	5
dasatinib —	2006	36.591	Pleura-effusie	1
nadolol —	1979	7.461	winderigheid uit de vagina	4
decitabine —	2006	4.930	Terugkerende acute myeloïde leukemie	3

Recall-geschiedenis · 11 geregistreerd

Datum	Klasse	Reden	Bedrijf
2 jul 2024	II	CGMP Deviations: Out of Specification for Total Aerobic Microbial Count (TAMC) test for unfiltered bulk for decitabine for injection.	SUN PHARMACEUTICAL INDUSTRIES INC
15 mrt 2021	II	CGMP Deviations: Intermittent exposure to temperature excursion during storage.	Cardinal Health Inc.
15 mrt 2021	II	CGMP Deviations: Intermittent exposure to temperature excursion during storage.	Cardinal Health Inc.
10 feb 2021	II	Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.	Teva Pharmaceuticals USA
12 jun 2019	II	Lack of Assurance of Sterility	Infusion Options, Inc.
12 jun 2019	II	Lack of Assurance of Sterility	Infusion Options, Inc.
5 mrt 2018	III	Failed impurities/degradation specifications: Failure to water content and impurity	InvaGen Pharmaceuticals, Inc.
22 dec 2016	II	Failed dissolution specification: recalled due to an out of specification dissolution result of 40% (Specification: NLT 80%)	Sandoz Incorporated
12 feb 2015	II	Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.	Health Innovations Pharmacy, Inc
14 nov 2014	II	Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.	Attix Pharmaceuticals
14 nov 2014	II	Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.	Attix Pharmaceuticals

Class I = redelijke kans op ernstige schade · Class II = tijdelijk of omkeerbaar · Class III = onwaarschijnlijk schadelijk.

Registratiestatus

Sommige producten van BluePoint Laboratories zijn niet FDA-geregistreerd voor humaan gebruik. Voor ongeregistreerde stoffen (peptiden, SARMs zonder humane registratie) bestaat geen legitieme leverancier voor humaan gebruik. Het ontbreken van een inkooproute is de veiligheidsinformatie.